Class II · Moderate risk
Oxcarbazepine Oral Suspension
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Is Oxcarbazepine recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Oxcarbazepine (10 total). Check the affected lots below.
Most common reason: Labeling / mix-up (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Oxcarbazepine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Oxcarbazepine recalls on record
none so far in 2026; 10 on record, newest first
Class II · Moderate risk
Oxcarbazepine Tablets 600mg
Presence of foreign substance
Class II · Moderate risk
Oxcarbazepine Oral Suspension
Failed Impurities/Degradation Specificattion
Class II · Moderate risk
Oxcarbazepine active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class I · High risk
Oxcarbazepine Tablets
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544.
Class II · Moderate risk
Oxcarbazepine Tablets
Failed Tablet Specifications: Broken Tablets Present.
Class II · Moderate risk
OXcarbazepine Tablet
Labeling:Label Mixup; OXcarbazepine Tablet, 600 mg may be potentially mislabeled as LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: AD30028_25, EXP: 5/7/2014.
Class II · Moderate risk
OXcarbazepine Tablet
Labeling:Label Mixup; OXcarbazepine Tablet, 150 mg may be potentially mislabeled as traZODone HCl, Tablet, 50 mg, NDC 50111043301, Pedigree: AD54562_1, EXP: 5/20/2014.
Class II · Moderate risk
Oxcarbazepine Oral Suspension
Resuspension Problems: Recalled lot did not meet resuspendability requirements.
Class III · Low risk
Oxcarbazepine Tablets
SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
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